DEVICE: PLASMALINK Bottle, 1000 mL with Locking Luer Adapter (04086000100342)

Device Identifier (DI) Information

PLASMALINK Bottle, 1000 mL with Locking Luer Adapter
6R2069
In Commercial Distribution
6R2069
Fresenius Kabi AG
04086000100342
GS1

1
315654579 *Terms of Use
For the collection, storage, and shipment of plasma prior to fractionation. Sterile Fluid Path.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44904 Blood/tissue storage/culture container
A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK080033 0
BK180293 0
BK190362 0
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at Room Temperature. Avoid excessive heat.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a4fc6d9b-43fb-4088-bdb0-9b610e66de0a
June 13, 2023
5
September 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14086000100349 12 04086000100342 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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